BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 10215008 · Received June 30, 2020

    Report

    Report Number
    1051786-2020-00035
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Report Date
    June 25, 2020
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT WIRELESS SPO2 MODULE AND WIRELESS MODULE BATTERY, WHICH REMAIN AT THE CUSTOMER SITE. THE EVALUATION OF THE WIRELESS SPO2 MODULE DID NOT REVEAL ANY PROBLEMS WITH THE MODULE AND DID NOT CONCLUDE THAT THE MODULE CAUSED OR CONTRIBUTED TO THE THERMAL HEATING EVENT. THE INITIAL CONCLUSION FROM THE BATTERY SUPPLIER IS THAT THE EVENT WAS NOT A RESULT OF THE BATTERY¿S DESIGN AND THAT THE BATTERY MET DESIGN SPECIFICATIONS. AS OF THE CLOSING OF THIS COMPLAINT INVESTIGATION, THE SUPPLIER IS CONTINUING TO LOOK FOR OTHER AVENUES FOR THIS EVENT TO OCCUR. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WIRELESS MODULE BATTERY OVERHEATED AND MELTED WHEN INSERTED INTO A WIRELESS MODULE. THE DEVICE WAS NOT IN USE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680068 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 453564185581

    Patients

    Seq Age Sex Outcome Treatment
    1